Jakavi 10 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Jakavi 5 mg tablets

Jakavi 10 mg tablets

Jakavi 15 mg tablets

Jakavi 20 mg tablets

ruxolitinib

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• The information in this leaflet is intended for you or your child – although the leaflet refers only to "you".

Leaflet Contents

1. What Jakavi is and what it is used for
2. What you need to know before taking Jakavi
3. How to take Jakavi
4. Possible side effects
5. How to store Jakavi
6. Contents of the pack and other information

1. What Jakavi is and what it is used for

Jakavi contains the active substance ruxolitinib.

Jakavi is used to treat adult patients with an enlarged spleen or symptoms related to myelofibrosis, a rare blood cancer.

Jakavi is also used to treat adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.

Jakavi is also used to treat:

• children aged 28 days and older and adults with acute graft-versus-host disease (GVHD), and
• children aged 6 months and older and adults with chronic GVHD.

There are two forms of GVHD: an early form called acute GVHD, which usually develops shortly after transplantation and may affect the skin, liver, and gastrointestinal tract, and a later form called chronic GVHD, which develops weeks to months after transplantation. With chronic GVHD, almost any organ may be affected.

How Jakavi works

One of the features of myelofibrosis is spleen enlargement. Myelofibrosis is a disorder of the bone marrow in which the marrow is replaced by fibrous (scar) tissue. The abnormal marrow cannot produce enough normal blood cells, and as a result, the spleen becomes significantly enlarged. By blocking the action of certain enzymes (called Janus kinases), Jakavi can reduce spleen size in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain, and weight loss. Jakavi may help reduce the risk of serious blood or vascular complications.

Polycythaemia vera is a bone marrow disorder in which the marrow produces too many red blood cells. Blood becomes thicker as a result of the increased number of red blood cells. Jakavi can relieve symptoms, reduce spleen size and the volume of red blood cells produced in patients with polycythaemia vera by selectively blocking certain enzymes called Janus Kinases (JAK1 and JAK2), thereby potentially reducing the risk of serious blood or vascular complications.

Graft-versus-host disease is a complication that occurs after transplantation, when certain cells (T cells) from the donor graft (e.g. from bone marrow) do not recognize the recipient's cells/organs and attack them. Jakavi reduces the signs and symptoms of both acute and chronic forms of graft-versus-host disease by selectively blocking enzymes called Janus kinases (JAK1 and JAK2), leading to improvement in the disease and survival of the transplanted cells.

If you have any questions about how Jakavi works or why you have been prescribed this medicine, please consult your doctor.

2. What you need to know before taking Jakavi

Carefully follow all instructions given to you by your doctor. These may differ from the general information contained in this leaflet.

Do not take Jakavi

• if you are allergic to ruxolitinib or to any of the other components of this medicine (listed in section 6)
• if you are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and contraception”)

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Jakavi if:

• you have any infection. It may be necessary to treat the infection before starting treatment with Jakavi
• you have had tuberculosis or have been in close contact with someone who has or has had tuberculosis. Your doctor may perform tests to check whether you have tuberculosis or any other infection
• you have had hepatitis B
• you have kidney problems or have or have had liver problems, as your doctor may need to prescribe a different dose of Jakavi
• you have had cancer, particularly skin cancer
• you have or have had heart problems
• you are over 65 years of age. Patients aged 65 years or older may have an increased risk of heart problems, including myocardial infarction, and certain types of cancer
• you smoke or have smoked in the past

Inform your doctor or pharmacist during treatment with Jakavi if:

• you develop fever, chills, or other symptoms of infections
• you develop a chronic cough with blood-stained sputum, fever, night sweats, and weight loss (these may be signs of tuberculosis)
• you experience any of the following symptoms or if someone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, lack of coordination (clumsiness), difficulty speaking, decreased strength or weakness on one side of your body, blurred vision and/or loss of vision. These may be signs of a serious brain infection and your doctor may recommend additional tests and monitoring
• you develop a painful skin rash with blisters (these are signs of herpes)
• you notice any changes in your skin. This may require further examination, as some types of non-melanoma skin cancer have been reported
• you suddenly experience shortness of breath or difficulty breathing, chest pain or upper back pain, swelling in your arms or legs, pain or tenderness in your legs, redness or color change in your arms or legs—these may be signs of blood clots in the veins

Children and adolescents

This medicine is not indicated for use in children or adolescents under 18 years of age with myelofibrosis or polycythemia vera, as it has not been studied in this age group.

For the treatment of graft-versus-host disease, Jakavi may be used in patients aged 28 days and older.

Other medicines and Jakavi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. While taking Jakavi, do not start taking any new medicine without first consulting the doctor who prescribed Jakavi. This includes prescription medicines, over-the-counter medicines, herbal products, or alternative medicines.

It is particularly important that you mention medicines containing any of the following active substances, as your doctor may need to adjust your dose of Jakavi.

The following medicines may increase the risk of adverse effects with Jakavi:

• Some medicines used to treat infections:
  • medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole, and voriconazole)
  • antibiotics used to treat bacterial infections (such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin)
  • medicines to treat viral infections, including HIV/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines for treating hepatitis C (boceprevir, telaprevir)
• a medicine used to treat depression (nefazodone)
• medicines used to treat high blood pressure (hypertension) and chest tightness, heaviness, or pain (chronic angina pectoris) (mibefradil or diltiazem)
• a medicine used to treat stomach acidity (cimetidine)
• a medicine used to treat heart disease (avasimibe)
• medicines used for seizures or fits (phenytoin, carbamazepine, or phenobarbital and other antiepileptics)
• medicines used to treat tuberculosis (rifabutin or rifampicin)
• a herbal product used to treat depression (St. John’s wort (Hypericum perforatum))

Talk to your doctor if you are unsure whether any of the above applies to you.

Pregnancy, breastfeeding and contraception

Pregnancy

• If you are pregnant or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
• Do not take Jakavi during pregnancy (see section 2 “Do not take Jakavi”).

Breastfeeding

• Do not breastfeed while being treated with Jakavi (see section 2 “Do not take Jakavi”).

Consult your doctor.

Contraception

• Jakavi is not recommended for women who could become pregnant and who are not using contraception. Discuss with your doctor the most appropriate contraceptive methods to prevent pregnancy while being treated with Jakavi.
• Inform your doctor if you become pregnant while taking Jakavi.

Driving and use of machines

If you experience dizziness after taking Jakavi, you should not drive or operate machinery.

Jakavi contains lactose and sodium

Jakavi contains lactose (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Jakavi

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment with Jakavi and during treatment, your doctor will request blood tests to determine the best dose, to monitor your response to treatment, and to check whether Jakavi is causing any adverse effects. Your doctor may need to adjust the dose or interrupt treatment. Before starting and during treatment with Jakavi, your doctor will check that you do not have signs or symptoms of infection.

Myelofibrosis

• Adults: The recommended starting dose in myelofibrosis is 5 mg to 20 mg twice daily. The maximum dose is 25 mg twice daily in adults.

Polycythemia vera

• Adults: The recommended starting dose in polycythemia vera is 10 mg twice daily. The maximum dose is 25 mg twice daily in adults.

Graft-versus-host disease

• Children aged 6 to less than 12 years: The recommended starting dose in graft-versus-host disease is 5 mg twice daily in patients aged 6 to 12 years.
• Children aged 12 years and older and adults: The recommended starting dose in graft-versus-host disease is 10 mg twice daily for patients aged 12 years or older.

If you have difficulty swallowing the tablets whole, or for children under 6 years of age, an oral solution is available. Ask your doctor or pharmacist.

You should take Jakavi every day at the same time, with or without food.

Your doctor will always tell you exactly how many Jakavi tablets you should take.

You should continue taking Jakavi for as long as your doctor advises. This is a long-term treatment.

If you take more Jakavi than you should

If you accidentally take more Jakavi than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Jakavi

If you forget to take Jakavi, simply take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Jakavi can cause adverse effects, although not everyone experiences them.

Most adverse effects with Jakavi are mild to moderate and usually disappear after a few days to a few weeks of treatment.

Myelofibrosis and polycythaemia vera

Some adverse effects may be serious

Seek immediate medical attention before taking the next dose if you experience any of the following serious adverse effects:

Very common (may affect more than 1 in 10 people):

• any sign of bleeding in the stomach or intestines, such as black or bloody stools, or vomiting blood
• unexpected bruising and/or bleeding, unusual tiredness, difficulty breathing during exercise or at rest, unusual paleness, or frequent infections – possible symptoms of blood disorders
• painful skin rash with blisters – possible symptoms of shingles (herpes zoster)
• fever, chills, or other signs of infection
• low red blood cell count (anaemia), low white blood cell count (neutropenia), or low platelet count (thrombocytopenia)

Common (may affect up to 1 in 10 people):

• any sign of bleeding in the brain, such as sudden change in level of consciousness, persistent headache, numbness, tingling, weakness, or paralysis

Other adverse effects with Jakavi

Other possible adverse effects are listed below. If you experience any of these adverse effects, speak with your doctor or pharmacist.

Very common (may affect more than 1 in 10 patients):

• high cholesterol or fat levels in the blood (hypertriglyceridaemia)
• abnormal liver function test results
• dizziness
• headache
• urinary tract infections
• weight gain
• fever, cough, difficulty or pain breathing, wheezing, chest pain when breathing – possible symptoms of pneumonia
• increased blood pressure (hypertension), which may also cause dizziness or headaches
• constipation
• high levels of lipase in the blood

Common (may affect up to 1 in 10 patients):

• low levels of all three types of blood cells – red blood cells, white blood cells, and platelets (pancytopenia)
• frequent passing of gas (flatulence)

Uncommon (may affect up to 1 in 100 patients):

• tuberculosis
• reactivation of hepatitis B infection (which may cause yellowing of the skin and eyes, dark brown urine, pain on the right side of the abdomen, fever, nausea, or feeling unwell)

Graft-versus-host disease

Some adverse effects may be serious

Seek immediate medical attention before taking the next dose if you experience any of the following serious adverse effects:

Very common (may affect more than 1 in 10 people):

• signs of infection with fever associated with:
  • muscle pain, redness of the skin and/or difficulty breathing (cytomegalovirus infection)
  • pain when urinating (urinary tract infection)
  • rapid heartbeat, confusion, and rapid breathing (sepsis, a condition associated with infection and widespread inflammation)
• frequent infections, fever, chills, sore throat, or mouth ulcers
• spontaneous bleeding or bruising – possible symptoms of thrombocytopenia due to low platelet levels

Other adverse effects

Very common (may affect more than 1 in 10 patients):

• headache

• high blood pressure (hypertension)

• abnormal blood test results:

  • high levels of lipase and/or amylase
  • high cholesterol levels
  • abnormal liver function

• increased levels in the blood of muscle enzyme (increased blood creatine phosphokinase)

• elevated creatinine levels, an enzyme indicating impaired kidney function

• low counts of all three types of blood cells: red blood cells, white blood cells, and platelets (pancytopenia)

• feeling unwell (nausea)

• tiredness, fatigue, paleness – possible symptoms of anaemia due to low red blood cell levels

Common (may affect up to 1 in 10 patients):

• fever, muscle pain, or pain or difficulty urinating, blurred vision, cough, cold, or difficulty breathing – possible symptoms of BK virus infection
• weight gain
• constipation

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Jakavi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister after «CAD/EXP».

Do not store above 30 ºC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Jakavi

• The active substance in Jakavi is ruxolitinib.
• Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
• Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
• Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
• Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
• The other components are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate (see section 2), povidone, hydroxypropylcellulose, lactose monohydrate (see section 2).

Appearance of the product and pack contents

Jakavi 5 mg tablets are round, white to off-white tablets with the inscription "NVR" engraved on one side and "L5" on the other.

Jakavi 10 mg tablets are round, white to off-white tablets with the inscription "NVR" engraved on one side and "L10" on the other.

Jakavi 15 mg tablets are oval, white to off-white tablets with the inscription "NVR" engraved on one side and "L15" on the other.

Jakavi 20 mg tablets are elongated, white to off-white tablets with the inscription "NVR" engraved on one side and "L20" on the other.

Jakavi tablets are supplied in blister packs containing 14 or 56 tablets, or multiple packs containing 168 tablets (3 packs of 56).

Only certain pack sizes may be available in your country.

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana
Slovenia

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu